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Hepatitis B, Chronic clinical trials

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NCT ID: NCT03214302 Recruiting - Chronic Hepatitis B Clinical Trials

The Incidence of Postpartum Hepatitis in Pregnant Women With Chronic Hepatitis B Virus Infection

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

The majority of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level. However, there is no withdrawal time recommendations after childbirth at present.Through the study of hepatitis occurrence after delivery and drug withdrawal, the investigators explore the withdrawal time of antiviral treatment during pregnancy.

NCT ID: NCT03210506 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of Cytokines During Antiviral Therapy

Start date: January 2016
Phase: N/A
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, cytokines played a vital role. This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α therapy resulted in the secretion of cytokines.

NCT ID: NCT03210493 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of Treg Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: N/A
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, Treg cells Regulatory T cells played a negative role in immune. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.

NCT ID: NCT03210467 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: N/A
Study type: Observational

Pegylated interferon(IFN) α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while entecavir(ETV) drugs only inhibit viral replication. In hepatitis B infection, Plasmacytoid Dendritic Cells(pDCs) are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of pDCs frequency and function, and the expression of costimulatory molecules CD86(Cluster of Differentiation antigen 86) during Peg-IFN-αand entecavir(ETV) therapy.Meanwhile, investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of pDCs function, or Peg-IFN-α enhanced pDCs function which gave rise to the decline of the virus.

NCT ID: NCT03209908 Recruiting - Chronic Hepatitis B Clinical Trials

The Study of Short-range Antiviral Treatment During Pregnancy to Block Mother-to-child Transmission of Hepatitis B Virus and Withdrawal Time

Start date: January 1, 2017
Phase: N/A
Study type: Observational

Pregnant women carry high HBV DNA loads before delivery, which is the most important factor leading to mother-to-child transmission of HBV. Nucleoside analogue antiviral treatment during late pregnancy can significantly reduce the incidence of HBV MTCT, but security problems of using NA treatment during pregnancy has not been eliminated, Therefore, the aim of our study is to explore the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

NCT ID: NCT03209037 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of CD8+T Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, CD8+T cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of CD8+T cells function, or Peg IFN - alpha enhanced CD8+T cells function which gave rise to the decline of the virus.

NCT ID: NCT03209011 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of CD4+T Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, CD4+T Cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD4+T Cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of CD4+T Cells function, or Peg IFN - alpha enhanced CD4+T Cells function which gave rise to the decline of the virus.

NCT ID: NCT03208998 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of Natural Killer Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, NKs are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of NKs frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of NKs function, or Peg IFN - alpha enhanced NKs function which gave rise to the decline of the virus.

NCT ID: NCT03181607 Enrolling by invitation - Chronic Hepatitis b Clinical Trials

Efficacy and Adverse Effects of Nucleoside Analogues (TDF/LDT) in Preventing Mother-to-child Transmission of HBV

Start date: January 1, 2017
Phase:
Study type: Observational

Mother-to-Child-Transmission (MTCT) of HBV is the most important route in high endemic countries. Although active-passive immune prophylaxis is generally administrated to infants delivered by HBsAg positive women, there are a lot of people infected with HBV in China. High HBV DNA load (>10^5IU/ml) is the vital cause of MTCT. So some researchers used TDF (tenofovir) or LDT(telbivudine) to treat patients with high HBV DNA load during middle, late pregnancy, in order to decrease MTCT. As a result, some data about it were gradually reported in late years. Recently, American Association for the Study of Liver Diseases, European Association for the Study of Liver Diseases and China guidelines for CHB (chronic hepatitis B) suggest that pregnant women with high HBV DNA load be treated with TDF or LDT at 24-28 weeks of gestation to lower MTCT of HBV. Although TDF or LDT is classified as pregnancy B drugs by FDA, and many studies report that MTCT rate of HBV decreases after women with high HBV DNA load are administrated with TDF or LDT at 24-28 weeks of gestation, a few birth defects are reported. Furthermore, the long-effect of TDF or LDT on infants remains unclear thoroughly. Some CHB women had severe liver dysfunction before pregnancy or during pregnancy, and routine liver protection therapy could not effect. Some of them could develop into liver failure, fibrosis, cirrhosis, and even died. Moreover, severe liver dysfunction often leads to adverse effects to pregnant women and fetuses, such as pregnancy failure, lower weight, premature birth, etc. As a result, these women have to accept TDF or LDT before pregnancy, or during early pregnancy. So the long-effect of TDF or LDT on infants needs thoroughly investigating. Taken together, the investigators will enroll women with chronic HBV infection and evaluate their state of illness. Then the investigators treat participants with TDF or LDT or routine liver protection therapy, and follow up the participants for a long period. The investigators' objectives are as follows: A, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT between immune-tolerant and immune-active CHB patients. B, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT during different trimesters of pregnancy. C, To compare MTCT rate between patients received TDF/LDT therapy and patients without TDF/LDT therapy. D, To compare MTCT rate and adverse effects between LDT and TDF.

NCT ID: NCT03181113 Completed - Hepatitis B Clinical Trials

Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy

Start date: May 18, 2016
Phase:
Study type: Observational

In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.